TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief
- Product NDC
- 50580-142
- 11-digit product format
- 505800142
- Labeler code
- 50580
- Product ID
- 50580-142_2611d7e2-4446-b6b6-e063-6394a90a6232
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Lidocaine, Menthol
- Dosage form
- KIT
- Labeler
- Kenvue Brands LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-11-25
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2611e984-0dd5-bda1-e063-6394a90a559a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-142-01 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 1 in 1 KIT | KIT | 1 | 1 | |
| 50580-490-25 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 225 in 1 BOTTLE | TABLET, COATED | 225 | 500 mg | 1 |
| 50580-490-25 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 1 in 1 CARTON | TABLET, COATED | 500 mg | 1 | |
| 69968-0793-1 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 1 in 1 CARTON | CREAM | 40 mg in 1g | 1 | |
| 69968-0793-1 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 14.2 g in 1 TUBE | CREAM | 14.2 g | 40 mg in 1g | 1 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Equaline Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | United Natural Foods, Inc. dba UNFI | 739237a5-cc62-8ad6-e053-2991aa0a91f8 | 2024-12-17 | Warnings | M013 |
| NOTTS - Muscle Aches and Pain | ACETAMINOPHEN | VIVUNT PHARMA LLC | e6741300-4573-2580-e053-2a95a90a599c | 2024-12-17 | Warnings | M013 |
| Extra Strength Pain Reliever, Caseys 4good | ACETAMINOPHEN 500MG, FILM-COATED CAPLET | Lil' Drug Store Products, Inc. | e5fc5340-c224-e02b-e053-2a95a90a5297 | 2024-12-16 | Warnings | M013 |
| Pain Reliever, Caseys 4good | ACETAMINOPHEN 500 MG, TABLET | Lil' Drug Store Products, Inc. | 039d2cf1-57f6-4d9d-e063-6394a90a5492 | 2024-12-16 | Warnings | M013 |
| Extra Strength Headache, Caseys 4good | ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET | Lil' Drug Store Products, Inc. | 0425c6a8-a3ea-24ad-e063-6294a90ae15a | 2024-12-16 | Warnings | M013 |
| Lil Drug Store Childrens Pain and Fever | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | 5fcd41ad-449f-4090-be19-eae4171de891 | 2024-12-16 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e75551-1e50-9896-e053-2a95a90aafd4 | 2024-12-14 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e5df0e-06d3-6f72-e053-2995a90a2d07 | 2024-12-14 | Warnings | M013 |
| Alka-Seltzer Heartburn and Pain | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Bayer HealthCare LLC. | 2928e140-c868-5bf5-e063-6394a90ab024 | 2024-12-13 | Warnings | M013 |
| foster and thrive pain reliever | ACETAMINOPHEN | Strategic Sourcing Services LLC | b8ee568c-80cf-4e35-865e-35516bdab0fd | 2024-12-13 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | c0de0bd2-4868-46dc-a20f-3ca02caaa26b | 2024-12-11 | Warnings | M013 |
| Rite Aid Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Rite Aid | b4797380-9cef-d640-e053-2a95a90a0665 | 2024-12-11 | Warnings | M013 |
| Top Value Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE | Tower Laboratories Ltd | 44babed8-cf38-1c12-e054-00144ff8d46c | 2024-12-11 | Warnings, Adverse reactions | M013 |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | b5e2300a-b77b-53cc-e053-2a95a90a7a6e | 2024-12-11 | Warnings | M013 |
| EXTRA STRENGTH Headache Relief geltabs | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | b432771a-4f7d-4d39-a038-d1561d8f6708 | 2024-12-11 | Warnings | M013 |
| Pain Relief Childrens | ACETAMINOPHEN | QUALITY CHOICE (Chain Drug Marketing Association) | 223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6 | 2024-12-10 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | UNFI | e689c9e3-dd4d-c646-e053-2a95a90a4b6a | 2024-12-09 | Warnings | M013 |
| DrKids Childrens Pain and Fever | ACETAMINOPHEN 80MG/PIECE | CalmCo LLC | ff4b0528-39a0-80d5-e053-6394a90a8a83 | 2024-12-07 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | 2024-12-05 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | DISCOUNT DRUG MART | e6feff0a-3347-194d-e053-2a95a90acd20 | 2024-12-05 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 250912 | lidocaine 4 % / menthol 1 % Topical Cream | PSN | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 209459 | Tylenol Extra Strength 500 MG Oral Tablet | PSN | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 209459 | acetaminophen 500 MG Oral Tablet [Tylenol] | SBD | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 250912 | lidocaine 40 MG/ML / menthol 10 MG/ML Topical Cream | SCD | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 198440 | APAP 500 MG Oral Tablet | SY | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 209459 | APAP 500 MG Oral Tablet [Tylenol] | SY | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 250912 | lidocaine 4 % / menthol 1 % Topical Cream | SY | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 209459 | Tylenol 500 MG Oral Tablet | SY | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
| 209459 | Tylenol Extra Strength 500 MG Oral Tablet | SY | 2611e984-0dd5-bda1-e063-6394a90a559a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50580-142-01 | 50580014201 | 1 KIT in 1 KIT (50580-142-01) * 1 BOTTLE in 1 CARTON (50580-490-25) / 225 TABLET, COATED in 1 BOTTLE * 1 TUBE in 1 CARTON (69968-0793-1) / 14.2 g in 1 TUBE | 1 kit | 2024-11-25 | No | No | Current |
| 50580-490-25 | 50580049025 | 225 in 1 BOTTLE | Historical | ||||
| 69968-0793-1 | 69968079301 | 1 in 1 CARTON | Historical |